Job summary
We are recruiting for a Quality Control Pharmaceutical Microbiologist who shares our vision to be trusted to provide consistently outstanding care and exemplary service to our patients.
You will be a suitably qualified professional with significant practical experience of pharmaceutical microbiology. Ability to interpret the current standards and guidance applicable to sterile and non-sterile pharmaceutical facilities and ensure that any microbiology testing and monitoring is undertaken in line with the current industry standards in particular the Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and the Manufacture of Sterile Medicinal Products.
Lead the microbiology section of Quality Control Department and develop and deliver pharmaceutical and environmental microbiology and other non-clinical microbiological services. Train and develop staff and plan, organise and deliver high quality microbiology service to all internal and external customers of the Quality Control Department.
Our Values are Include, Respect and Improve. It is important that you understand and refer to our values during your recruitment process and beyond!
Main duties of the job
Main duties of this role include leadership of the microbiology section of the Quality Control Department, interpretation of current standards, writing and updating of standard operating procedures, staff training a development as well as participation in Quality Management Activities as part of delivery of high quality microbiology services to pharmaceutical and other healthcare facilities.
About us
At East and North Hertfordshire NHS Trust, we are proud of the range of general & specialist services we provide & our 6,000 or so dedicated staff ensure our patients get the best care. Our ability to be flexible & innovative in the way in which we work and deliver our services to our catchment has never been more important than it is now.
We run the following hospitals:
- The Lister Hospital, Stevenage
- New Queen Elizabeth II (New QEII), Welwyn Garden City
- Hertford County, Hertford
- Mount Vernon Cancer Centre (MVCC), Northwood
We have ambitious plans to become an outstanding, patient-led Trust where dedicated staff provide high-quality, compassionate care to our patients. We continue to undergo significant transformation; our staff & patients are at the heart of delivering this ambitious agenda.
We understand that finding and starting a new job is an important life decision. If you need reasonable adjustments for a disability, or a life event, such as menopause - so that we can consider your application fairly & to get the best out of you during the selection process, please let us know.
We are committed to a positive work life balance for our employees. Employees are entitled to seek to work flexible working patterns & we are committed to listen and consider all requests. Such requests, of course, have to be made & considered formally, & will need to be balanced against service needs, but our starting point will always be to find ways to support making them happen.
Job description
Job responsibilities
Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role.
Job description
Job responsibilities
Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role.
Person Specification
Qualifications / Training
Essential
- B.Sc. in a Biological Science or similar subject
- Significant post graduate experience in pharmaceutical microbiology environment.
- Postgraduate Diploma in Pharmaceutical Technology and Quality Assurance or equivalent postgraduate level of knowledge.
- Membership or eligibility for a membership of a suitable regulatory or professional organization/body e.g. the Royal Society of Biology/ chartered biologist status
Previous Experience
Essential
- Experience of working in GLP/GMP environment in QA/QC Department in Hospitals, Pharmaceutical or Biotechnology industry.
- Management/leadership experience as well as demonstrated experience of staff training, development and performance management and assessing staff competencies
- Experience of writing, reviewing and approving standard operating procedures
- Experience of microbiological environmental monitoring within pharmaceutical manufacturing facilities including of trend analysis of environmental monitoring data and of generating environmental monitoring reports.
- Experience of variety of microbiological laboratory techniques including handling hazardous materials.
Skills
Essential
- Good interpersonal skills and the ability to communicate with all levels of staff and individuals within and outside of the department with confidence, assertiveness and tact. Excellent customer care skills
- Ability to work with a variety of high precision laboratory and other relevant equipment requiring a high degree of hand-eye co-ordination, manual dexterity and visual & colour acuity.
- Ability to work at speed accurately
- Ability to concentrate and maintain accuracy for long periods of time when analysing data/results and undertaking testing.
- Ability to concentrate and maintain accuracy for long periods of time when analysing data/results and undertaking testing
Knowledge
Essential
- Ability to use the technical knowledge, reasoning and professional judgement to critically review and assess highly complex data and information relating to facilities and products in order to evaluate their suitability for their intended use
- Knowledge of Information technology to include Microsoft Word, Excel, Access and Power Point
- Knowledge of current legislation and guidelines relating to pharmaceutical PQMS, GMP, GLP, GCP.
- Knowledge of validation requirements for pharmaceutical facilities, equipment and processes
- Advanced knowledge of microbiological techniques
- Knowledge of Health and Safety at Work act, COSHH legislation and laboratory safety issues and risk assessments
- Understanding of waste management regulations.
Other Requirements
Essential
- Required to wear full PPEs as appropriate for work in laboratory environment or in sterile aseptic facilities and work sitting or standing for prolonged periods of time, The post holder may be required to work in aseptic facilitiesRequired to wear full PPEs as appropriate for work in laboratory environment or in sterile aseptic facilities and work sitting or standing for prolonged periods of time, The post holder may be required to work in aseptic facilities
- Required to have the ability to carry and handle moderately heavy equipment.
- Required to have the ability to occasionally work at height and also in confined spaces.
- Required to be flexible and willing to work out of hours and at weekends to meet customer service demands.
- Ability to travel easily between Trust Sites
- Experience and evidence of engagement around equality, diversity and inclusion issues in relation to policy, service development and service delivery in respect of both services to users and the management of staff
- Role model our Trust values every day
Person Specification
Qualifications / Training
Essential
- B.Sc. in a Biological Science or similar subject
- Significant post graduate experience in pharmaceutical microbiology environment.
- Postgraduate Diploma in Pharmaceutical Technology and Quality Assurance or equivalent postgraduate level of knowledge.
- Membership or eligibility for a membership of a suitable regulatory or professional organization/body e.g. the Royal Society of Biology/ chartered biologist status
Previous Experience
Essential
- Experience of working in GLP/GMP environment in QA/QC Department in Hospitals, Pharmaceutical or Biotechnology industry.
- Management/leadership experience as well as demonstrated experience of staff training, development and performance management and assessing staff competencies
- Experience of writing, reviewing and approving standard operating procedures
- Experience of microbiological environmental monitoring within pharmaceutical manufacturing facilities including of trend analysis of environmental monitoring data and of generating environmental monitoring reports.
- Experience of variety of microbiological laboratory techniques including handling hazardous materials.
Skills
Essential
- Good interpersonal skills and the ability to communicate with all levels of staff and individuals within and outside of the department with confidence, assertiveness and tact. Excellent customer care skills
- Ability to work with a variety of high precision laboratory and other relevant equipment requiring a high degree of hand-eye co-ordination, manual dexterity and visual & colour acuity.
- Ability to work at speed accurately
- Ability to concentrate and maintain accuracy for long periods of time when analysing data/results and undertaking testing.
- Ability to concentrate and maintain accuracy for long periods of time when analysing data/results and undertaking testing
Knowledge
Essential
- Ability to use the technical knowledge, reasoning and professional judgement to critically review and assess highly complex data and information relating to facilities and products in order to evaluate their suitability for their intended use
- Knowledge of Information technology to include Microsoft Word, Excel, Access and Power Point
- Knowledge of current legislation and guidelines relating to pharmaceutical PQMS, GMP, GLP, GCP.
- Knowledge of validation requirements for pharmaceutical facilities, equipment and processes
- Advanced knowledge of microbiological techniques
- Knowledge of Health and Safety at Work act, COSHH legislation and laboratory safety issues and risk assessments
- Understanding of waste management regulations.
Other Requirements
Essential
- Required to wear full PPEs as appropriate for work in laboratory environment or in sterile aseptic facilities and work sitting or standing for prolonged periods of time, The post holder may be required to work in aseptic facilitiesRequired to wear full PPEs as appropriate for work in laboratory environment or in sterile aseptic facilities and work sitting or standing for prolonged periods of time, The post holder may be required to work in aseptic facilities
- Required to have the ability to carry and handle moderately heavy equipment.
- Required to have the ability to occasionally work at height and also in confined spaces.
- Required to be flexible and willing to work out of hours and at weekends to meet customer service demands.
- Ability to travel easily between Trust Sites
- Experience and evidence of engagement around equality, diversity and inclusion issues in relation to policy, service development and service delivery in respect of both services to users and the management of staff
- Role model our Trust values every day
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
